Anesthesia AwarenessNCT03476213
Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
A study testing Group TCI and Group TIVA in people with Anesthesia Awareness, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Awareness
- What is being tested?
- Group TCI and Group TIVA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Mar 2018to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma scale 15
- ASA Physical Status Classification System I - III
- planed surgery for brain tumor to 5 hours
- postoperative awakening
Who cannot join
- NYHA III, IV
- abuse of stimulating drugs, grass, alcohol dependence
- BMI over 40 in females and over 35 in men
- propofol alergie
- awake operations
- postoperative arteficial ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
Suchy Tomas, MD, 00420495833218, suchy@fnhk.cz
Dostal Pavel, MD, PhD, 00420495832828, pavel.dostal@fnhk.cz
About this study
Official title: Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.
Read the detailed description
Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.
- Conditions
- Anesthesia Awareness
- Being tested
- Group TCI, Group TIVA
- Keywords
- Anesthesia Awareness, Dreaming in anesthesia, Total intravenous anesthesia, Target-controll infusion
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TCIProcedure or surgery
Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.
Group TIVAProcedure or surgery
Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.
| Study group | Role | What they receive |
|---|---|---|
| Group TCI | Experimental | induction and anesthesia will be held by using target-controll infusion Receives: Procedure: Group TCI |
| Group TIVA | Active comparator | induction and anesthesia will be held by manual dosing of propofol and sufentanil Receives: Procedure: Group TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of awareness
consciousness during operation
Measured: 5 hours
Secondary outcomes (2)
reduction of haemodynamical instability
reduction of blood pressure by 25 %
Measured: 5 hours
reduction of norepinephrine dose
reduction in ugs during the whole operation
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start16 Mar 2018
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will be anesthetized using TIVA, group B using TCI
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Pavel Dostal, MD, Ph.D., Study director, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476213
- Sponsor's protocol ID
- 201506S
- Status last verified
- May 2024
- First submitted
- 9 Mar 2018
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
- ClinicalTrials.gov ID
- NCT03476213
- Acronym / sponsor ID
- 201506S
- Conditions
- Anesthesia Awareness
- Keywords
- Anesthesia Awareness, Dreaming in anesthesia, Total intravenous anesthesia, Target-controll infusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.
Detailed description
Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will be anesthetized using TIVA, group B using TCI
| Arm | Type | Receives |
|---|---|---|
| Group TCI | Experimental | Procedure: Group TCIinduction and anesthesia will be held by using target-controll infusion |
| Group TIVA | Active comparator | Procedure: Group TIVAinduction and anesthesia will be held by manual dosing of propofol and sufentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Glasgow Coma scale 15
- ASA Physical Status Classification System I - III
- planed surgery for brain tumor to 5 hours
- postoperative awakening
Key exclusion criteria (6 listed)
- NYHA III, IV
- abuse of stimulating drugs, grass, alcohol dependence
- BMI over 40 in females and over 35 in men
- propofol alergie
- awake operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group TCIInduction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35. | Procedure or surgery | Group TCI |
| Group TIVAInduction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35. | Procedure or surgery | Group TIVA |
Primary outcome
reduction of awareness
Time frame: 5 hours
consciousness during operation
2 secondary outcomes
reduction of haemodynamical instability
Time frame: 5 hours
reduction of norepinephrine dose
Time frame: 5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pavel Dostal, MD, Ph.D. study director
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group TCI and Group TIVA in people with Anesthesia Awareness, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vlasta Dostalova, MD. Ph.D. (+420777883571, vlasta.dostalova@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of awareness (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.